Category - Recast

medicaldeviceslegal

EU member states show some of their cards on medical devices revision

The EU member states have so far been the dark horse in the discussions surrounding the revision of the EU medical devices directives, keeping their cards close to their chest and not getting involved in the largely fact free politics surrounding the ENVI rapporteurs’ drafts for the medical devices and IVD regulations. Council of Employment, […]

medicaldeviceslegal

Euro update and Don’t Lose The SME

While the medical devices and IVD regulation proposals trickle through the legislative process and people concentrate on details like I have done on this blog as well, it might be nice to have a higher level picture. So that’s what my UK colleague Alex Denoon and I prepared for a recent webinar, and what we […]

medicaldeviceslegal

ENVI’s 29 may debate on medical devices

The fog of war that I wrote about with respect to the tsunami of amendments is lifting with the discussion of the amendments in the ENVI committee today. It was a very interesting debate, and I’ll share my impression of it with you. I have grouped what I heard by subjects so it’s easier to […]

medicaldeviceslegal

ENVI’s IVD regulation amendments

As promised, here is an analysis of the IVD amendments further to the report provided by rapporteur Liese, with numbers 75-237 and 238-399. Not that as many as the medical devices ones, but still a lot – and no less complex. I won’t repeat all the procedural proposals that are both in the medical devices […]

medicaldeviceslegal

ENVI’s amendments

ENVI’s amendments, following those of IMCO  have been published now after translation, see here for IVDs and here for medical devices. This accounts for the biggest load of the amendments (297 – 907 on medical devices and 75 – 399 on IVDs), but here is a list of the things that I found particularly interesting. […]

medicaldeviceslegal

The fog of war following a tsunami of amendments

That’s a good term to describe a situation of limited situaltional awareness resulting from many things happening at the same time very quickly, and a good term to decribe the situation we are currently in with the medical devices and IVD regulation proposals and the amendments proposed. Tsunami of amendments The period for tabling amendments […]

medicaldeviceslegal

eHealth and mHealth at the DIA Euromeeting

I had the privilege to preside a session about eHealth and mHealth at the DIA Euromeeting in Amsterdam last week, joined by Mr Tapani Piha, Head of Unit for eHealth, Health Technology Assessment and Science of DG SANCO of the European Commission and Mrs Marianne Fournier of Voisin Consulting. In a lively session we took […]